欧盟肥料法 2019 修改要点

I
(Legislative acts)
REGULATIONS
REGULATION (EU) 2019/1009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 June 2019
laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee ( 1 ),
Acting in accordance with the ordinary legislative procedure ( 2 ),
Whereas:
(1) The conditions for making fertilisers available on the internal market have been partially harmonised through Regulation (EC) No 2003/2003 of the European Parliament and of the Council ( 3 ), which almost exclusively covers fertilisers from mined or chemically produced, inorganic materials. There is also a need to make use of recycled or organic materials for fertilising purposes. Harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use. Promoting increased use of recycled nutrients would further aid the development of the circular economy and allow a more resource-efficient general use of nutrients, while reducing Union dependency on nutrients from third countries. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.
(2) Certain products are being used in combination with fertilisers for the purpose of improving nutrition efficiency, with the beneficial effect of reducing the amount of fertilisers used and hence their environmental impact. In order to facilitate their free movement on the internal market, not only fertilisers, i.e. products intended to provide plants with nutrient, but also products intended to improve plants’nutrition efficiency, should be covered by the harmonisation.
(3) Regulation (EC) No 765/2008 of the European Parliament and of the Council ( 4 ) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. That Regulation should be applicable to products covered by this Regulation in order to ensure that products benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of public interests such as human, animal and plant health, safety and the environment. (4) Decision No 768/2008/EC of the European Parliament and of the Council ( 5 ) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Regulation (EC) No 2003/2003 should therefore be replaced by
this Regulation, drafted to the extent possible in accordance with those common principles and reference provisions.
(1)欧洲议会(European Parliament)和理事会(Council) 2003/2003号法规(EC)对国内市场供应化肥的条件进行了部分协调，该法规几乎完全涵盖了来自开采或化学生产的无机材料的化肥。

此外，还需要利用可回收或有机材料来施肥。

应制订协调的条件，使由这种可回收或有机材料制成的肥料能在整个国内市场上销售，以便为这些肥料的进一步使用提供重要的鼓励。

促进更多地使用再生营养物质将进一步有助于发展循环经济，并使更有效地普遍使用营养物质，同时减少联盟对第三国营养物质的依赖。

因此，协调的范围应该扩大，以包括回收和有机材料。

(2)某些产品正与肥料结合使用，以提高营养效率，从而减少肥料的使用量，从而减少对环境的影响。

为了促进它们在国内市场上的自由流动，不仅应包括肥料，即旨在为植物提供营养的产品，而且还应包括旨在提高植物营养效率的产品。

(3)调节(EC) 765/2008号的欧洲议会和理事会(4)制定了规则符合性评估机构的认证,提供了一个框架为产品的市场监测和控制产品从第三国,躺下来CE标志的一般原则。

该条例应适用于本条例所涵盖的产品，以确保受益于联盟内货物自由流动的产品符合对公众利益，如人类、动植物健康、安全和环境等，提供高度保护的要求。

(4)欧洲议会和理事会第768/2008/EC号决定(5)规定了旨在适用于跨部门立法的共同原则和参考条款，以便为该立法的修订或重订提供一致的基础。

因此，第2003/2003号规例应由本规例取代，并尽可能根据这些共同原则和参考条文草拟本规例。

(5) Contrary to most other product harmonisation measures in Union law, Regulation (EC) No 2003/2003 does not prevent non-harmonised fertilisers from being made available on the internal market in accordance with national law and the general free movement rules of the Treaty on the Functioning of the European Union (TFEU). In view of the very local nature of certain product markets, this possibility should remain. Compliance with harmonised rules should therefore remain optional, and should be required only for products, intended to provide plants with nutrient or improve plants’ nutrition efficiency, which are CE marked when made available on the market. This Regulation should therefore not apply to products which are not CE marked when made available on the market.
(6) Different product functions warrant different product safety and quality requirements adapted to their different intended uses. EU fertilising products should therefore be divided into different product function categories, which should each be subject to specific safety and quality requirements.
(7) An EU fertilising product might have more than one of the functions described in the product function categories set out in this Regulation. Where only one of those functions is claimed, it should be sufficient for the EU fertilising product to comply with the requirements of the product function category describing that claimed function. By contrast, where more than one of those functions are claimed, the EU fertilising product should be regarded as a blend of two or more component EU fertilising products, and compliance should be required for each of the component EU fertilising products with respect to its function. A specific product function category should therefore cover such blends.
(8) A manufacturer using one or more EU fertilising products that have already been subject to a conformity assessment, by that manufacturer or another manufacturer, might wish to rely on that conformity assessment. For the purpose of reducing the administrative burden to a minimum, the resulting EU fertilising product should also be regarded as a blend of two or more component EU fertilising products, and the additional conformity requirements for the blend should be limited to the aspects that are warranted by the blending.
(5)与其他大多数产品在联盟协调措施法律,法规(EC) 2003/2003号不防止non-harmonised化肥提供内部市场依照国家法律和一般的自由流动规则,欧盟条约的功能(TFEU)。

鉴于某些产品市场的地域性，这种可能性应该仍然存在。

因此，遵守协调的规则仍然是可选的，而且只应要求为植物提供营养或提高植物营养效率的产品，这些产品在市场上出售时应标明CE。

因此，本规例不应适用于市面上出售的没有CE标记的产品。

(6)不同的产品功能保证了不同的产品安全和质量要求，以适应其不同的预期用途。

因此，欧盟的肥料产品应划分为不同的产品功能类别，每个类别都应符合特定的安全和质量要求。

(7)欧盟的肥料产品可能具有本规例所列产品功能类别所述的功能之一以上。

只有其中一项功能被声明，欧盟肥料产品应足以符合描述该声明功能的产品功能类别的要求。

与此相反，如果声称欧盟肥料产品具有以上一种功能，则应将其视为欧盟肥料产品的两种或两种以上成分的混合物，并应要求欧盟肥料产品的每一种成分都符合其功能。

因此，一个特定的产品功能类别应该包括这样的混合物。

(8)使用欧盟一种或多种已接受该生产商或另一生产商的合格评定的肥料产品的生产商，可能希望依赖该合格评定。

为了减少行政负担降到最低,由此产生的欧盟产品也应该被视为一个混合施肥两个或更多组件的欧盟产品、施肥和额外的一致性要求的混合应限于方面合理的混合。

(9) Different component materials warrant different process requirements and control mechanisms adapted to their different potential hazardousness and variability. Component materials for EU fertilising products should therefore be divided into different categories, which should each be subject to specific process requirements and control mechanisms. It should be possible to make available on the market an EU fertilising product composed of several component materials from various component material categories, where each material complies with the requirements of the category to which the material belongs.
(10) Contaminants in EU fertilising products, such as cadmium, could pose a risk to human, animal or plant health, to safety or to the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in EU fertilising products derived from bio- waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing.
(11) Several Member States have in place national provisions limiting cadmium content in phosphate fertilisers on grounds relating to the protection of human health and of the environment. Should a Member State deem it necessary to maintain such national provisions after the adoption of harmonised limit values under this Regulation,and until those harmonised limit values are equal to or lower than the national limit values already in place, it should notify them to the Commission in accordance with Article 114(4) TFEU. Furthermore, in accordance with Article 114(5) TFEU, if a Member State deems it necessary to introduce new national provisions, such as provisions limiting cadmium content in phosphate fertilisers, based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of this Regulation, it should notify the Commission of the envisaged provisions as well as the grounds for introducing them. In either case, the Commission should verify in accordance with Article 114(6) TFEU whether or not the notified national provisions are a means of arbitrary discrimination, a disguised restriction on trade or an obstacle to the functioning of the internal market.
(12) In view of the fact that certain Member States have been granted derogations from Article 5 of Regulation (EC) No 2003/2003 in accordance with TFEU relating to cadmium content in fertilisers on the grounds, inter alia, of the protection of human health and the environment in the context of particular soil and climactic
conditions prevailing in those Member States, and since the factual circumstances that led to the granting of those derogations by the Commission remain valid, those Member States should be able to continue to apply their national limit values for cadmium content until such time as harmonised limit values for cadmium content in phosphate fertilisers which are equal to or lower than those limit values are applicable at Union level.
(9)不同的组分材料需要不同的工艺要求和控制机制，以适应其不同的潜在危险性和可变性。

因此，欧盟肥料产品的成分材料应划分为不同的类别，每个类别都应符合特定的工艺要求和控制机制。

应可在市场上提供一种欧盟肥料产品，该产品由来自不同成分材料类别的若干成分材料组成，其中每一种材料均符合该材料所属类别的要求。

(10)欧盟肥料产品中的污染物，如镉，可能对人类、动物或植物的健康、安全或环境构成威胁，因为它们在环境中积累并进入食物链。

因此，这些产品的内容应受到限制。

此外，欧盟肥料产品中来自生物废料的杂质，特别是聚合物，也包括金属和玻璃，应在技术可行的范围内加以防止或限制，方法是在处理前在单独收集的生物废料中检测这些杂质。

(11)若干会员国已制定国家规定，以保护人类健康和环境为理由，限制磷肥中的镉含量。

应成员国认为有必要保持这样的国家规定统一限制值通过后根据本条例,直到这些统一限制值等于或低于全国限额值已经到位,应该通知他们委员会依照本法第114条(4)TFEU。

此外,依照第114条(5)TFEU,如果成员国认为有必要引入新的国家规定,如规定限制磷酸盐化肥镉含量,根据新的科学证据有关的保护环境或问题的工作环境为由特定于该成员国本条例通过后,它应将所设想的规定以及提出这些规定的理由通知委员会。

在这两种情况下，委员会应根据第114条第6款核查所通知的国家规定是否为任意歧视的手段、对贸易的变相限制或对国内市场运作的障碍。

(12)的事实,某些成员国已获得减损的第五条规定(EC) 2003/2003号按照TFEU有关镉含量化肥为由,尤其,保护人类健康和环境的上下文特定的土壤和气候条件的成员国,因为事实的情况下,授予了减损的委员会仍然有效,这些会员国应能够继续适用其国家镉含量限值，直到在联盟一级适用等于或低于这些限值的磷肥中镉含量的协调限值为止。

(13) In order to facilitate the compliance of phosphate fertilisers with the requirements of this Regulation and to boost innovation, sufficient incentives should be provided for the development of relevant technologies, particularly decadmiation technology, and for the management of cadmium-rich hazardous waste in the form of relevant financial resources such as those available under Horizon Europe, the Circular Economy Finance Support Platform or through the European Investment Bank. Those incentives should target cadmium removal solutions that will be economically viable on an industrial scale and allow appropriate treatment of the waste generated.
(14) An EU fertilising product complying with the requirements of this Regulation should be allowed to move freely on the internal market. Where one or more of the component materials is a derived product within the meaning of Regulation (EC) No 1069/2009 of the European Parliament and of the Council ( 6 ), but has reached a point in the manufacturing chain beyond which it no longer poses any significant risk to human, animal or plant health, to safety or to the environment (the ‘end point in the manufacturing chain’), to continue subjecting the product to the provisions of that Regulation would represent an unnecessary administrative burden. Such fertilising products should therefore be excluded from the requirements of that Regulation. Regulation (EC) No 1069/2009 should therefore be amended accordingly.
(15) For each component material category which includes derived products within the meaning of Regulation (EC) No 1069/2009, the end point in the manufacturing chain should be determined in accordance with the procedures laid down in that Regulation. Where such an end point is reached before the EU fertilising product is placed on the market but after the manufacturing process regulated under this Regulation has started,
the process requirements of both Regulation (EC) No 1069/2009 and this Regulation should apply cumulatively to EU fertilising products, which means application of the stricter requirement in case both Regulations regulate the same parameter.
(16) Derived products within the meaning of Regulation (EC) No 1069/2009 which are already placed on the market and used in the Union as organic fertilisers and soil improvers in accordance with that Regulation constitute promising raw materials for the production of innovative fertilising products in a circular economy. As soon as an end point in the manufacturing chain has been determined for the respective derived product, the EU fertilising products containing such derived products in accordance with this Regulation should be granted free movement on the internal market without being subject to the requirements of Regulation (EC) No 1069/2009. For this purpose, the Commission should, without undue delay, carry out a first assessment to check whether an end point in the manufacturing chain can be determined.
(13)为了促进磷肥的合规的要求监管和促进创新,充分激励应提供相关技术的发展,特别是decadmiation技术,管理和cadmium-rich危险废物的形式相关的金融资源,比如那些可用的地平线下的欧洲,循环经济金融支持平台或通过欧洲投资银行。

这些奖励措施应针对工业规模上经济可行的镉去除解决办法，并允许对产生的废物进行适当处理。

(14)符合本规例要求的欧盟肥料产品，应获准在内部市场自由流通。

在一个或多个组件的材料是派生产品内部监管的意义(EC) 1069/2009号的欧洲议会和理事会(6),但制造链中达到一个点超出它不再对人类构成任何重大风险,动植物健康、安全或环境(“制造链的终点”),继续使产品符合该条例的规定将构成不必要的行政负担。

因此，这些肥料产品应该被排除在该法规的要求之外。

因此，规例(欧洲共同体)第1069/2009号须作出相应修订。

(15)对于每一个组件材料类别，包括《规例》(欧洲共同体)第1069/2009号所指的衍生产品，其制造链的终点应按照该规例所订明的程序确定。

这样一个到达终点之前欧盟产品施肥放在后的市场,但这个规定已经开始下生产过程监管,监管的流程需求(EC) 1069/2009号和本条例累计应适用于欧盟频率较低的产品,这意味着应用程序更严格要求的情况下两个法规规范相同的参数。

(16)《规例》(欧洲共同体)第1069/2009号所指的衍生产品已投放市场，并根据该规例在欧盟用作有机肥料及土壤改良剂，是在循环经济下生产创新肥料产品的理想原料。

尽快制造链的终点已经确定了各自的派生产品,含有这样的派生产品的欧盟能依照本条例应该允许在内部市场自由流动而不受监管的需求(EC) 1069/2009号。

为此目的，委员会应毫不拖延地进行第一次评估，以检查能否确定制造链的一个终点。

(17) In the event of risks to public or animal health from fertilising products derived from animal by-products, recourse to safeguard measures in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 7 ) should be possible, as is the case for other categories of products derived from animal by-products.
(18) The making available on the market of an animal by-product or a derived product within the meaning of Regulation (EC) No 1069/2009 for which no end point in the manufacturing chain has been determined, or for which the determined end point has not been reached at the time of making available on the market, is subject to the requirements of that Regulation. Therefore, it would be misleading to provide for the product’s CE marking under this Regulation. Any product containing or consisting of such an animal by-product or derived product should therefore be excluded from the scope of this Regulation. Untreated animal by-products should not be subject to this Regulation.
(19) For certain recovered wastes, such as struvite, biochar and ash-based products, within the meaning of Directive 2008/98/EC of the European Parliament and of the Council ( 8 ), a market demand for their use as fertilising products has been identified. Furthermore, certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques, as well as for fertilising products resulting from the recovery operation, in order to ensure that the use of those fertilising products does not lead to overall adverse environmental or human health impacts. For EU fertilising products, those requirements should be laid down in this Regulation. Therefore, as of the moment of compliance with all the requirements of this Regulation, such products should cease to be regarded as waste within the meaning of Directive 2008/98/EC, and it should, therefore, be possible for fertilising products containing or consisting of such recovered waste materials to access the internal market. To ensure legal certainty, take advantage of technical developments, and further stimulate the incentive among producers to make more use of valuable waste streams, the scientific analyses and the setting of recovery requirements at Union level for such products should start immediately after the entry into force of this Regulation. Accordingly, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of defining, without unnecessary delay, larger or additional categories of component materials eligible for use in the production of EU fertilising products.
(20) Certain by-products within the meaning of Directive 2008/98/EC are currently used by manufacturers as components of fertilising products or can be expected to be used in future emerging markets. For such components, specific requirements should be laid down in a separate component material category in Annex II to this Regulation.
(17)在公共或动物卫生风险从受精产品来源于动物副产品,求助于依照监管保障措施(EC) 178/2002号的欧洲议会和理事会(7)应该是可能的,对其他类别的产品一样来自动物副产品。

(18)的市场上提供一个动物副产品或衍生产品监管的意义(EC) 1069/2009号的没有终点制造链中确定,或确定的终点没有达到市场上提供的时候,受到监管的要求。

因此，在本规定下对产品的CE标识进行规定是有误导性的。

因此，任何含有或由此类动物副产品或衍生产品组成的产品均应排除在本规例的范围之外。

未经处理的动物副产品不适用本规定。

(19)根据欧洲议会和理事会指示2008/98/EC(8)所指的若干回收废物，例如鸟粪石、生物炭和以灰渣为基础的产品，已确定其作为肥料产品的市场需求。

此外,某些需求复苏所必需的废物作为输入操作和治疗过程和技术,以及所引起的频率较低,产品恢复操作,以确保使用的频率较低,产品不会导致整体不良环境或人类健康的影响。

对于欧盟的化肥产品，这些要求应在本规定中作出规定。

因此,作为的时刻遵守所有本条例的要求,此类产品应该不再被视为浪费在指令2008/98 / EC的意义,它应该,因此,有可能恢复等组成的频率较低,产品包含或废料来访问内部市场。

为确保法律的确定性，利用技术发展，并进一步刺激生产者更多地利用有价值的废物流，应在本条例生效后立即开始对这类产品进行科学分析和在联盟一级制定回收要求。

因此，应将根据第290条TFEU通过法案的权力授予委员会，以便在没有不必要拖延的情况下确定更大或更多类别的成分材料，使其有资格用于生产欧盟肥料产品。

(20)《指示2008/98/EC》所指的某些副产品，目前正被制造商用作肥料产品的成分，或预期可用于未来的新兴市场。

对于这些部件，应在本条例附件二的单独部件材料类别中规定具体要求。

(21) Certain substances and mixtures, commonly referred to as inhibitors, improve the nutrient release pattern of a nutrient in a fertiliser by delaying or stopping the activity of specific groups of micro-organisms or enzymes. For inhibitors made available on the market with the intention of them being added to fertilising
products, the manufacturer should be responsible for ensuring that those inhibitors fulfil certain efficacy criteria. Therefore, those inhibitors should be considered as EU fertilising products under this Regulation. Furthermore, EU fertilising products containing such inhibitors should be subject to certain efficacy, safety and environmental criteria. Such inhibitors should therefore also be regulated as component materials for EU fertilising products.
(22) Certain substances, mixtures and micro-organisms, referred to as plant biostimulants, are not as such inputs of nutrients, but nevertheless stimulate plants’ natural nutrition processes. Where such products aim solely at improving the plants’ nutrient use efficiency, tolerance to abiotic stress, quality traits or increasing the availability of confined nutrients in the soil or rhizosphere, they are by nature more similar to fertilising products than to most categories of plant protection products. They act in addition to fertilisers, with the aim of optimising the efficiency of those fertilisers and reducing the nutrient application rates. Such products should therefore be eligible for CE marking under this Regulation and excluded from the scope of Regulation (EC) No 1107/2009 of the European Parliament and of the Council ( 9 ). Regulation (EC) No 1107/2009 should therefore be amended accordingly.
(23) Products with one or more functions, one of which is covered by the scope of Regulation (EC) No 1107/2009, are plant protection products falling within the scope of that Regulation. Those products should remain under the control developed for such products and provided for by that Regulation. Where such products also have the function of a fertilising product, it would be misleading to provide for their CE marking under this Regulation, since the making available on the market of a plant protection product is contingent on a product authorisation valid in the Member State concerned. Therefore, such products should be excluded from the scope of this Regulation.
(21)某些物质和混合物，通常称为抑制剂，通过延迟或停止特定微生物群或酶的活性，改善肥料中养分的释放模式。

对于市场上销售的抑制剂，并打算将其添加到肥料产品中，制造商应负责确保这些抑制剂满足某些疗效标准。

因此，这些抑制剂应被认为是欧盟在这一规定下的肥料产品。

此外，欧盟含有此类抑制剂的肥料产品应符合一定的有效性、安全性和环境标准。

因此，这些抑制剂也应作为欧盟肥料产品的组成材料加以监管。

(22)某些物质、混合物和微生物，称为植物生物刺激剂，不是作为营养的输入物，而是刺激植物的自然营养过程。

如果这些产品的目的仅仅是提高植物的养分利用效率、对非生物胁迫的耐受性、品质性状或增加土壤或根际中有限养分的供应，它们在性质上更类似于肥料产品，而不是大多数种类的植物保护产品。

除了肥料，它们还能发挥作用，目的是优化肥料的效率，降低养分的利用率。

因此，该等产品应符合根据本规例进行CE标记的资格，并被排除在欧洲议会及理事会(9)规例(欧洲共同体)第1107/2009号的范围之外。

因此，规例(欧洲共同体)第1107/2009号须作出相应修订。

(23)具有一项或多项功能的产品，其中一项属于规例(欧洲共同体)第1107/2009号所涵盖的产品，是属于该规例范围内的植保产品。

这些产品应保持在为这些产品开发并由该条例规定的控制之下。

如该等产品同时具有肥料的功能，则根据本规例为该等产品提供CE标记会误导人，因为在市场上供应植物保护产品，须视有关成员国有效的产品授权而定。

因此，此类产品应被排除在本规定的范围之外。

(24) This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of human, animal and plant health, of safety and of the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC ( 10 ), Council Directive 89/391/EEC ( 11 ), Council Directive 91/676/EEC ( 12 ), Directive 2000/60/EC of the European Parliament and of the Council ( 13 ), Directive 2001/18/EC of the European Parliament and of the Council
( 14 ), Regulation (EC) No 852/2004 of the European Parliament and of the Council ( 15 ), Regulation (EC) No 882/2004 of the European Parliament and of the Council ( 16 ), Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 17 ), Commission Regulation (EC) No 1881/2006 ( 18 ), Council Regulation (EC) No 834/2007 ( 19 ), Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 20 ), Regulation (EU) No 98/2013 of the European Parliament and of the Council ( 21 ), Regulation (EU) No 1143/2014 of the European Parliament and of the Council ( 22 ), Regulation (EU) 2016/2031 of the European Parliament and of the Council ( 23 ), Directive (EU) 2016/2284 of the European Parliament and of the Council ( 24 ) and Regulation (EU) 2017/625 of the European Parliament and of the Council ( 25 ).
(25) In line with common practice, nitrogen, phosphorus and potassium should be referred to as ‘primary macronutrients’, and calcium, magnesium, sodium and sulphur should be referred to as ‘secondary macronutrients’. Also in line with common practice, fertilisers should be referred to as ‘straight’when they contain either only one macronutrient –regardless whether it is primary or secondary –or only one primary macronutrient in combination with one or more secondary macronutrients. In line with the same practice, fertilisers should be referred to as ‘compound’when they contain either more than one primary macronutrient – regardless whether they also contain one or more secondary macronutrients – or contain no primary macronutrient but more than one secondary macronutrient.
(26) Where an EU fertilising product contains a substance or mixture within the meaning of Regulation (EC) No 1907/2006, the safety of its constituent substances for the intended use should be established through registration pursuant to that Regulation. The information requirements should ensure that the safety of the intended use of the EU fertilising product is demonstrated in a manner comparable to that achieved through other regulatory regimes for products intended for use on arable soil or crops, notably Member States’national fertiliser legislation and Regulation (EC) No 1107/2009. Therefore, where the actual quantities placed on the market are lower than 10 tonnes per company per year, the information requirements determined by Regulation (EC) No 1907/2006 for the registration of substances in quantities of 10 to 100 tonnes should exceptionally apply as a condition for use in EU fertilising products. Those information requirements should apply to the actual substances contained in the EU fertilising product, as opposed to the precursors used for the manufacturing of those substances. The precursors themselves, such as sulphuric acid used as a precursor for the production of single superphosphate, should not be regulated as component materials for the purpose of this Regulation, since chemical safety will be better ensured by regulating as component materials the substances formed from the precursors and actually contained in the EU fertilising product. The obligation to comply with all the requirements of a component material category should therefore apply to those substances.
(27) Where the actual quantities of substances in EU fertilising products regulated by this Regulation are higher than 100 tonnes, the additional information requirements laid down in Regulation (EC) No 1907/2006 should apply directly by virtue of that Regulation. The application of the other provisions of Regulation (EC) No 1907/2006 should also remain unaffected by this Regulation.
(24)本条例不应妨碍有关保护本条例所不包括的人、动植物健康、安全及环境等方面的现有联盟立法的适用。

适用本条例应不影响理事会指令86/278 / EEC(10)、理事会指令89/391 / EEC(11)理事会指令91/676 / EEC(12),指令2000/60 / EC的欧洲议会和理事会(13),指令2001/18 / EC的欧洲议会和理事会(14),监管(EC) 852/2004号的欧洲议会和理事会(15),监管(EC) 882/2004号的欧洲议会和理事会(16),监管(EC) 1907/2006号的欧洲议会和理事会(17),监管委员会(EC) 1881/2006号(18),(EC) 834/2007号理事会条例(19),监管(EC) 1272/2008号的欧洲议会和理事会(20),监管(欧盟)没有98/2013的欧洲议会和理事会(21),监管(欧盟)没有1143/2014的欧洲议会和理
事会(22),《欧洲议会及理事会(23)规例(欧盟)2016/2031》、《欧洲议会及理事会(24)指引(欧盟)2016/2284》及《欧洲议会及理事会(25)规例(欧盟)2017/625》。

(25)根据一般惯例，氮、磷和钾应称为“一级宏量营养素”，钙、镁、钠和硫应称为“二级宏量营养素”。

同样，按照通常的做法，如果肥料只含有一种主要或次要的大量营养素，或者只有一种主要的大量营养素与一种或多种次要的大量营养素结合，就应称为“直接”肥料。

按照同样的做法，当肥料含有一种以上的初级宏量营养素时(不论它们是否也含有一种或多种次级宏量营养素)，或者不含有初级宏量营养素而含有一种以上次级宏量营养素时，应称为“化合物”。

(26)如欧盟肥料产品含有规例(欧洲共同体)第1907/2006号所指的物质或混合物，则须根据该规例进行注册，以确定其成分物质的预期用途是否安全。

信息需求应该确保安全使用的欧盟产品演示的方式与施肥通过其他监管制度产品使用耕地土壤和作物,特别是成员国国家肥料立法和监管(EC) 1107/2009号。

因此,实际的数量放在市场低于10吨每年公司,信息需求由监管(EC) 1907/2006号注册的物质数量的10至100吨应该特别适用条件在欧盟使用频率较低的产品。

这些信息要求应适用于欧盟肥料产品中所含的实际物质，而不是用于制造这些物质的前体。

前体本身,如硫酸作为单一的生产过磷酸钙的前兆,不应规定作为本条例的目的的组成材料,因为化学品安全会更好确保通过调节组件材料中包含的物质形成的前兆和实际上欧盟频率较低的产品。

因此，遵守组成部分材料类别的所有要求的义务应适用于这些物质。

(27)如本规例所规管的欧盟肥料产品的实际物质含量超过100公吨，则根据该规例应直接适用《欧洲共同体》第1907/2006号规例所订明的额外资料规定。

规例(欧洲共同体)第1907/2006号的其他条文的适用亦不应受本规例的影响。

(28) Economic operators should be responsible for the compliance of EU fertilising products with this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the aspects of public interest covered by this Regulation, and also to guarantee fair competition on the internal market. Whenever appropriate, manufacturers and importers should carry out sample testing of the EU fertilising products that they have made available on the market, in order to protect the health and safety of consumers and the environment.
(29) It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.
(30) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment of EU fertilising products should therefore remain solely the obligation of the manufacturer.
(31) It is necessary to ensure that EU fertilising products from third countries that enter the internal market comply with this Regulation, and in particular that the appropriate conformity assessment procedures have been carried out by manufacturers with regard to those EU fertilising products. Provision should therefore be made for importers to make sure that EU fertilising products which they place on the market comply with the requirements of this Regulation and that they do not place on the market EU fertilising products which do not comply with such requirements or present a risk to human, animal or plant health, to safety or to the environment. Provision should also be made for such importers to make sure that conformity assessment procedures have been carried out and that marking of EU fertilising products and documentation drawn up by manufacturers are available for inspection by the competent national authorities.。